Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001337864
Ethics application status
Approved
Date submitted
17/06/2021
Date registered
5/10/2021
Date last updated
15/02/2023
Date data sharing statement initially provided
5/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a parental preparation video (Take 5) on child and parent anxiety during anaesthetic induction. A randomised controlled trial.
Scientific title
The effect of a parental preparation video (Take 5) on child and parent anxiety during anaesthetic induction. A randomised controlled trial.
Secondary ID [1] 304504 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 322371 0
Perioperative anxiety 322372 0
Condition category
Condition code
Anaesthesiology 320034 320034 0 0
Other anaesthesiology
Mental Health 320374 320374 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents in the intervention group will watch a short video prior to accompanying their child to have a general anaesthetic. The video contains information on what to expect and positive behavioural approaches. The video duration will be 5 minutes and the study investigator will watch the video with the parent to ensure compliance.
Intervention code [1] 320866 0
Behaviour
Comparator / control treatment
The control group will receive standard preoperative preparation. This includes a consultation with the anaesthetist to discuss the procedure. Typically this consultation takes 5 to 10 minutes and includes taking a medical history and explaining the anesthetic, including a discussion of risks and an opportunity for parents to ask questions.
Control group
Active

Outcomes
Primary outcome [1] 327897 0
Child anxiety (measured using the Modified Yale Preoperative Anxiety Scale - mYPAS and the Perioperative Adult-Child Behavior Interaction Scale - PACBIS)
Timepoint [1] 327897 0
At the time of anaesthetic induction
Primary outcome [2] 327898 0
Parent anxiety (measured using the Perioperative Adult-Child Behavior Interaction Scale - PACBIS)
Timepoint [2] 327898 0
At the time of anaesthetic induction
Secondary outcome [1] 396949 0
Child pain (measured using the FACES pain scale)
Timepoint [1] 396949 0
Immediately post procedure during recovery from general anaesthesia
Secondary outcome [2] 396950 0
Child anxiety (measured using the Visual Analogue Anxiety Scale - VAS-A)
Timepoint [2] 396950 0
Immediately post procedure during recovery from general anaesthesia.
Secondary outcome [3] 396951 0
Parent anxiety (measured using the Visual Analogue Anxiety Scale - VAS-A)
Timepoint [3] 396951 0
Immediately post procedure during recovery from general anaesthesia.
Secondary outcome [4] 396952 0
Child emergence delirium (measured using the Cornell Assessment of Pediatric Delirium -CAP-D)
Timepoint [4] 396952 0
Immediately post procedure during recovery from general anaesthesia.
Secondary outcome [5] 396953 0
Parental satisfaction - measured using a numeric rating scale from 0 to 10
Timepoint [5] 396953 0
Prior to hospital discharge
Secondary outcome [6] 396954 0
Cost effectiveness - measured by comparing the cost of the intervention (time, staff costs) to benefits from the intervention (time in recovery, duration of hospital admission, readmissions/general practitioner visits, time off school, parental time off work). Data will be collected from a combination of hospital records and parental survey results. This survey will be designed specifically for this trial. A health economist associated with the study will design the analysis.
Timepoint [6] 396954 0
3 months post procedure
Secondary outcome [7] 396955 0
Child psychological well-being - measured using the PROMIS-EC (parent proxy report) and the CHU9D (parent proxy report)
Timepoint [7] 396955 0
3 months post procedure
Secondary outcome [8] 396956 0
Parent psychological well-being - measured using the Depression Anxiety and Stress Scale (DASS-21)
Timepoint [8] 396956 0
3 months post procedure
Secondary outcome [9] 396957 0
Acceptability - measured by parental subjective ratings of the video on a numeric rating scale from 0 to 10
Timepoint [9] 396957 0
Prior to discharge from hospital

Eligibility
Key inclusion criteria
Age 3 to 10 years inclusive
Booked for an elective procedure
Minimum age
3 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented developmental disorder or global development delay.
Emergency surgery.
Child is under the care of the Department of Safety.
The parent speaks insufficient English to provide informed consent without the aid of a translator.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to groups will be performed by an online randomisation program. This program will be centralised and hosted by a secure internet server.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation will be performed by an online randomisation program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of this study was children’s anxiety at anaesthesia induction as measured by the Modified Yale Preoperative Anxiety Scale (mYPAS). Our estimate of e?ect is based on the validation of ‘Take 5’ in a cohort of children with burn-injuries and the ADVANCE preparation program. Assuming a clinically meaningful di?erence in anxiety (15-point di?erence on the mYPAS), with a mean control group score = 55 and a mean intervention group score = 40, a corresponding e?ect size of 0.61 was used for these analyses. Therefore, a sample of 50 participants per group is anticipated to provide >90% power to detect this e?ect size (a < 0.05).

Between-group comparisons of the primary outcome will use multilevel modelling of anxiety and distress over time. Continuous secondary outcomes will be compared using Student’s t-tests, mean di?erences and e?ect sizes, and non-continuous or count outcomes by Pearson’s chi-squared analysis. The primary analysis will be ‘intention-to-treat’. A within trial cost-e?ectiveness analysis will be conducted. Resource consumptions (and cost) will be collected for both arms (standard and interventions). Primary outcomes of behaviour and anxiety, and the secondary outcome (quality of life) will be used. Incremental cost and e?ectiveness (outcomes) will be calculated, and the incremental cost per e?ectiveness ratio (ICER) will be the primary result.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/10/2021
Actual
6/07/2022
Date of last participant enrolment
Anticipated
14/03/2023
Actual
Date of last data collection
Anticipated
14/06/2023
Actual
Sample size
Target
100
Accrual to date
85
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19747 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 34388 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 308870 0
Charities/Societies/Foundations
Name [1] 308870 0
Children's Hospital Foundation
Country [1] 308870 0
Australia
Primary sponsor type
Individual
Name
Paul Lee-Archer
Address
Department of Anaesthesia
Level 7
Queensland Children's Hospital
501 Stanley St. South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 309786 0
None
Name [1] 309786 0
Address [1] 309786 0
Country [1] 309786 0
Other collaborator category [1] 281855 0
Individual
Name [1] 281855 0
Erin Brown
Address [1] 281855 0
Faculty of Medicine
The University of Queensland
Mayne Medical Building
288 Herston Road, Herston, QLD, 4006
Country [1] 281855 0
Australia
Other collaborator category [2] 281856 0
Individual
Name [2] 281856 0
Justin Kenardy
Address [2] 281856 0
School of Psychology
The University of Queensland
Sir Fred Schonell Dr. St Lucia, QLD, 4072
Country [2] 281856 0
Australia
Other collaborator category [3] 281857 0
Individual
Name [3] 281857 0
Cameron Graydon
Address [3] 281857 0
Department of Anaesthesia
Queensland Children's Hospital
501 Stanley St, South Brisbane, 4101
Country [3] 281857 0
Australia
Other collaborator category [4] 281859 0
Individual
Name [4] 281859 0
Alexandra Donaldson
Address [4] 281859 0
Department of Anaesthesia
Queensland Children's Hospital
501 Stanley St, South Brisbane, 4101
Country [4] 281859 0
Australia
Other collaborator category [5] 281860 0
Individual
Name [5] 281860 0
Vanessa Rich
Address [5] 281860 0
Department of Anaesthesia
Queensland Children's Hospital
501 Stanley St, South Brisbane, 4101
Country [5] 281860 0
Australia
Other collaborator category [6] 281861 0
Individual
Name [6] 281861 0
Kim-Huong Nguyen
Address [6] 281861 0
Centre for Health Services Research
Building 33, Princess Alexandra Hospital Campus,
Woolloongabba, QLD, 4102
Country [6] 281861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308776 0
Children's Health Queensland Human research Ethics Committee
Ethics committee address [1] 308776 0
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 308776 0
Australia
Date submitted for ethics approval [1] 308776 0
22/02/2021
Approval date [1] 308776 0
07/07/2021
Ethics approval number [1] 308776 0
HREC/21/QCHQ/73894
Ethics committee name [2] 309353 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 309353 0
The University of Queensland
Brisbane, QLD, 4072
Ethics committee country [2] 309353 0
Australia
Date submitted for ethics approval [2] 309353 0
01/07/2021
Approval date [2] 309353 0
21/07/2021
Ethics approval number [2] 309353 0
2021/HE001649

Summary
Brief summary
Undergoing surgery can be a stressful and anxiety provoking process both for parents and the child undergoing surgery. Children are particularly vulnerable to experiencing procedural anxiety in the context of anaesthetic induction, especially due to varying and developing cognitive abilities, inability to self-regulate, and limited knowledge and/or experience of the healthcare environment. Young children are especially unlikely to engage in self-coping strategies, and instead rely on primary attachment figures for emotional regulation and behavioural cues. Previous research has demonstrated that parents’ own responses are influential for paediatric procedural coping and distress. As such, providing parents of children undergoing surgery with psychoeducation resources which can reduce their anxiety and promote coping strategies for both them and their child, may reduce negative experiences and post-operative outcomes (e.g., emergence delirium, pain severity, increased analgesic requirements, and longer-term poor psychological sequelae). The “Take Five” video resource for parents is a newly developed resource for procedural distress, and preliminary data from a study in young children with burn injuries indicates it is effective for improving parent and child experiences of burn wound care. We believe that this resource has the potential to significantly improve anaesthetic induction for parents and children and reduce poor post-operative outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111842 0
Dr Paul Lee-Archer
Address 111842 0
Department of Anaesthesia
Level 7
Queensland Children's Hospital
501 Stanley St, South Brisbane, QLD, 4101
Country 111842 0
Australia
Phone 111842 0
+61 434712458
Fax 111842 0
Email 111842 0
[email protected]
Contact person for public queries
Name 111843 0
Dr Paul Lee-Archer
Address 111843 0
Department of Anaesthesia
Level 7
Queensland Children's Hospital
501 Stanley St, South Brisbane, QLD, 4101
Country 111843 0
Australia
Phone 111843 0
+61 434712458
Fax 111843 0
Email 111843 0
[email protected]
Contact person for scientific queries
Name 111844 0
Dr Paul Lee-Archer
Address 111844 0
Department of Anaesthesia
Level 7
Queensland Children's Hospital
501 Stanley St, South Brisbane, QLD, 4101
Country 111844 0
Australia
Phone 111844 0
+61 434712458
Fax 111844 0
Email 111844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of a parental preparation video (Take5) on child and parent anxiety during anaesthetic induction: a protocol for a randomised controlled trial.2023https://dx.doi.org/10.1186/s13063-023-07480-0
N.B. These documents automatically identified may not have been verified by the study sponsor.